CN102970944B - Support installation on support delivery system - Google Patents

Support installation on support delivery system Download PDF

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Publication number
CN102970944B
CN102970944B CN201180033155.XA CN201180033155A CN102970944B CN 102970944 B CN102970944 B CN 102970944B CN 201180033155 A CN201180033155 A CN 201180033155A CN 102970944 B CN102970944 B CN 102970944B
Authority
CN
China
Prior art keywords
support
sacculus
crimping
conduit
foley
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CN201180033155.XA
Other languages
Chinese (zh)
Other versions
CN102970944A (en
Inventor
詹森·万希韦尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Abbott Cardiovascular Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US12/831,878 priority Critical patent/US8752261B2/en
Priority to US12/831,878 priority
Application filed by Abbott Cardiovascular Systems Inc filed Critical Abbott Cardiovascular Systems Inc
Priority to PCT/US2011/043234 priority patent/WO2012006451A1/en
Publication of CN102970944A publication Critical patent/CN102970944A/en
Application granted granted Critical
Publication of CN102970944B publication Critical patent/CN102970944B/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9524Iris-type crimpers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • Y10T29/49895Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"]
    • Y10T29/49902Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"] by manipulating aligning means
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53022Means to assemble or disassemble with means to test work or product
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53039Means to assemble or disassemble with control means energized in response to activator stimulated by condition sensor
    • Y10T29/53061Responsive to work or work-related machine element
    • Y10T29/53065Responsive to work or work-related machine element with means to fasten by deformation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53909Means comprising hand manipulatable tool
    • Y10T29/53913Aligner or center
    • Y10T29/53917Tube with tube
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53978Means to assemble or disassemble including means to relatively position plural work parts
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53987Tube, sleeve or ferrule

Abstract

A kind of system (10) for being installed on foley's tube (19) by support (100), this system (10) includes that two location and adjustment station, said two location and station of harmonizing are used for preparation by using same crimp head to carry out support and the conduit crimped.This system was configured to before crimping automatically assemble support and conduit.Conduit and support are placed on computer-controlled bracket (42), and support and conduit are transported to crimp head (20) by this bracket (42).Before support and conduit being placed in crimping head, support is positioned between balloon-markers by automatic alignment system (74).

Description

Support installation on support delivery system
Technical field
The present invention relates to a kind of drug eluting medical device;More particularly, it relates to for by such as Polymer-supported The balloon expandable support of frame is installed to transport the system of sacculus, equipment and method.
Background technology
Figure 1A and Figure 1B describes the allotment for balloon expandable support pressure is received foley's tube of the prior art The perspective view at the crimping station of sacculus.Crimping station includes: crimping head 220;For working out such as, diameter reduces, continuous print crimps it Between the time of staying, the interactive screen 216 of program of crimping sequence of temperature control etc. of press-connection machine claw.Bracket 242 will Conduit 209 is directed at the opening 222 crimping head 220, and by conduit, distal end that support 100 and sacculus are positioned at 209b is advanced to crimp in head 220.Crimping head 220 includes three rollers 223,224 and 225, described three rollers 223, The adhesion sheet of polymeric material of cleaning is placed between press-connection machine claw and support 100 by 224 and 225, to avoid when having medicine Clad material accumulation on claw when multiple supports of polymer coating are crimped into foley's tube.
Figure 1B shows that the perspective view of bracket 242, bracket 242 include keeping slidably block 250 of conduit 209.Block 250 is used In by using handle 274 to be advanced to distal end of catheter end 209b and support 100 crimp in head 220 and by distal end of catheter End 209b and support 100 exit crimping head 220.Conduit 209 is maintained in the groove 252 being formed on block 250.Conduit The axle of 209 is maintained in groove 252 by a pair cylindrical bar 253,254, the pair of cylindrical bar 253,254 be rotated down with Before the axle of conduit is advanced to crimp in head 220 by opening 222, catheter shaft is limited in groove 252.Bar 253,254 From closed position, (as directed) rotates to open position, to allow by (as by indicated by A, B) rotary gemel clockwise Arm 253a, 254a and conduit 209 is removed from groove 252.Handle 255 is connected to hinge arms 253a, 254a and rotates along direction C So that hinge arms 253a, 254a are moved to open position.Guide rail 273 is connected to block 250 at block extension 250a.Block 250 energy Enough it is shifted through distance " S ".Operator by use handle 274 manually by distal end 209b and support 100 towards crimping Head 220 moves or moves away from crimping head 220.In guide rail 273 is received within the passage of supporting part 272 and through supporting The passage in portion 272 slides, and this supporting part 272 is installed to the workbench at press-connection machine station.Block 250 is received within support member 260 Interior and along support member 260 the groove of groove (not shown) slides.The abutting part 275 of support member 260 is used as stop part, so that what to show Time distal end of catheter end 209b be properly positioned in crimping head 220 in.
In operation, conduit 209 is manually placed in groove 252 by operator, and is protected by the handle that turns clockwise Hold conduit 209 in place so that bar 253,254 is navigated to the position shown in Figure 1B.Then, operator is manually by fixed for support 100 It is positioned at sacculus.Before being inserted into by distal end 209b in crimping head 220, operator must assure that support is properly located On sacculus, i.e. operator must guarantee that support was positioned at the labelling band of sacculus before being placed on by support in crimping head 220 Between so that support suitably will be expanded in the vascular system of patient as the balloons are inflated.Then, by promoting forward bracket Until block 250 touches or abuts stop part 275 and is advanced to support and sacculus crimp in head.When block 250 clashes into stop part When 275, support and sacculus are positioned in the desired position of crimping head.
Utilizing such as devices described above and/or production technology preparation stent-catheter assembly wherein, operator causes Support is loaded on sacculus by power in manually, and guarantees that assembly is properly positioned/harmonizes so that support suitably clamps It is burden weight to crimp head.In the case of producing polymer support-conduit tube component in enormous quantities, compared with metal rack May require that and spend in the more substantial time on polymer support that suitably crimps.Additionally, due to the length of allotment sacculus is Foreshorten to the length of about support, place before thus be accordingly used in immediately crimping and become more to become with the existing program of adjustment bracket Problem and time-consuming.Due to length of balloon, more closely length with support matches and (keeps away for when support is deployed in vivo Exempt from the purpose of the destruction to vascular tissue), the leeway that operator makes mistakes is little.Little size is provided, thus for support and sacculus Operator must be careful to guarantee that the fore-stock in crimping is appropriately positioned on sacculus.If the fore-stock in crimping does not has Be appropriately positioned on sacculus, then support and conduit both must be dropped.
Recognize that when by the external loading of such as crimp force and balloon expandable power, affected holding Polymer-supported The many factors of the performance of the polymer support of the structural intergrity of frame.These interact be complicated and the mechanism of action also It is not completely understood.According to this area, distinguish the type being expanded to allotment state by plastic deformation polymer, biology can The support absorbed is substantial amounts of and significant with the characteristic of the metal rack with similar functions.Produce and neutralize polymer support It is crimped onto in sacculus these and relevant challenge faced in U. S. application NO.12/776,317(attorney docket NO.62571.398) and U. S. application NO.12/772,116(attorney docket NO.62571.399) in be discussed.
Compared with metal rack, certain challenging aspect that has been proposed that of polymer support is: guarantee inciting somebody to action Substantial amounts of polymer support is crimped onto program during foley's tube required for acceptable yield, as at U. S. application NO.12/ 776,317(attorney docket 62571.398) and U. S. application NO.12/772,116(attorney docket 62571.399) in Detailed disclosure;And improve efficiency when substantial amounts of polymer support is crimped onto sacculus so that polymer support crimping Unacceptable delay is not forced at manufacture process by the level of production.The compression bonding apparatus when being used for crimping polymer support Operation is time-consuming, and current yield cannot meet requirement.
In view of the above, exist for such as existing in the case of polymer support is crimped onto foley's tube The needs that improve of compression joint technique.
Summary of the invention
The invention provides a kind of for support pressure being received the equipment of foley's tube, system and process.According to the disclosure An aspect, support installation system includes crimping head and a pair station, and the pair of erect-position, in the opposite side of crimping head, is used In position the first and second supports and conduit tube component and for before support pressure is received sacculus by the first and second supports It is aligned on its corresponding foley's tube.Crimping head is suitable to receive support and conduit tube component to perform pressure simultaneously by two stations Connect process.This system integration have computer-controlled process with reduce most prepare for crimping support and conduit with And typically require, during monitoring crimping process, the work carried out by the operator of such as technical staff.Due to exist little support and Conduit will be improperly positioned in crimping head this can cause the uneven crimping of the length through support, or The fore-stock of crimping does not has the probability suitably harmonized with balloon-markers, replaces the automatic of manual precompressed termination process , computer-controlled process can increase yield.By using automatic, computer-controlled process, it is possible to reduce crimping The required time, and the yield of product can be increased.Furthermore it is possible to obtain the more operating time so that multiple crimping Sequence can be monitored by same operator.
The advantage of the these and other of the present invention is particularly noteworthy when crimping polymer support.With Metal rack is different, and due to the inherent limitations of material compared with metal material, polymer support must be carried out with slower speed Crimping.This slower process can produce significant bottleneck in the production process of stent-catheter.Crimped by automated manual Operation, it is possible to significantly decrease the total time required for crimping polymer support.Gather owing to being suitable to the such as PLLA(of bearing support Left lactic acid) polymeric material more frangible than metal, therefore when crimping produce strut irregular bending or distortion time, Polymer support is the most sensitive to rupturing.Therefore, crimping head in coarse crimping such as, when support and conduit The uneven power applied by press-connection machine claw when not being suitably positioned at or be positioned in crimping head is more likely The strut of polymer support produces and ruptures.Therefore, the degree of accuracy during crimping and repeatability are to polymer support Say more crucial to increasing yield than metal rack.According to an aspect of the present invention, the crimping at polymer support is found Journey exists the more needs for automatization, but there are the less needs for automatization when crimping metal rack. The crimping sequence of polymer support can be about five times of metal rack.When this growth temporal 5 times of crimping is taken advantage of During with the quantity of the polymer support-sacculus assembly carrying out crimping during production process, plan and resource distribution propose Unique challenge, this is different from the time required for crimping metal rack and resource distribution.The main cause postponed is needs More slowly crimping polymeric material is to reduce the situation that crackle produces and spreads, and crimp jaws is being removed from rack surface Time reduce recoil.
Operator is needed manually to harmonize support in balloon-markers for support pressure is received the existing system of sacculus Between, support and sacculus assembly be properly inserted in crimping head, then in pilot process, whether checking bracket is fitted Local crimping.The present invention is by introducing for location and harmonizing and carry out the automated procedure of support and the conduit crimped, substantially gram Take the shortcoming that the most operator of needs completes these work.
According to the disclosure, this system can be configured to the manual working of below automatization:
Manually the distal end of conduit is positioned at the porch in aperture, the most manually support and conduit is advanced to In crimping head.According to an aspect of the present invention, operator the most such as by identifying the proximal balloon sealing of conduit It has been appropriately positioned in bracket bracket at computer relative to the laser inspection conduit of the appropriate location of datum mark After in being advanced to conduit and support under control crimp in head, support and conduit are automatically advanced to pressure by computer Pick in head.Laser orientation system or video camera may be used for positioning conduit relative to the appropriate location of bracket, and for The processor transmission that control bracket moves forward to crimp in head shows that stent-catheter has been appropriately positioned in crimping head Interior signal, once this signal is received, and actuator will be advanced to crimp in head by stent-catheter assembly.On the contrary, figure Device described in 1A-1B uses Mechanical stops 275 to show that stent-catheter assembly has been appropriately positioned in pressure to operator Pick in head.It has been found, however, that, this method navigating to stent-catheter assembly crimp in head can make support Shift relative to sacculus, so that support deviation is harmonized.Present invention recognize that, for Mechanical stops, even if finding to be suitable to Metal rack is positioned in crimping head, but also can bring problem to polymer support, particularly have when polymer support During more much larger than sacculus diameter.As a solution of this problem, use servo control mechanism to reduce support by phase For being advanced to stent-catheter assembly under the speed of the probability of sacculus motion crimp in head.
Manually support is harmonized between balloon-markers.According to an aspect of the present invention, imaging system is used for obtaining By mode identificating software, support and the image of conduit, the most such as, determine whether support is properly aligned.If support does not has Be properly aligned, then support is adjusted by the computer-controlled actuator of use relative to the position of balloon-markers. Actuator can be controlled by the servo control mechanism driven by processor, and this processor can use video camera or laser alignment System and the combination controller logic with or without feedback circuit that can be in course of adjustment.
The support on sacculus is manually reviewed to guarantee that support is not in press-connection machine after initial crimping or pre-crimping Shift relative to balloon-markers.If support is the most shifted, then operator is before being placed into support and conduit in press-connection machine Manually adjusting pole.According to a further aspect in the invention, it is loaded on bracket and operator is to pressure at stent-catheter assembly After termination process activates, crimping process is carried out under the control of the computer.Stent-catheter assembly is placed in crimping head, Perform pre-crimping, then from crimping head, withdraw from stent-catheter.Then, activate imaging system with checking bracket whether with ball Capsule labelling is harmonized.Examine support between balloon-markers after, again stent-catheter assembly is advanced to crimp head In to perform final crimping.Participation not necessarily with operator.
One by one perform above-mentioned manual processes, to be received by the second support pressure after the first support, then the first support Sacculus.According to a further aspect in the invention, arrange crimping head with in a crimping sequence synchronously to the first support and leading Pipe assembly and the second support and conduit tube component crimp.Thus, after above-mentioned automatic location, adjustment and pre-crimping step Inspection two supports and conduit tube component can be performed simultaneously.
The present invention solves the need of the alignment procedure for improving the stent-catheter assembly requiring accurate adjustment tolerance Want.More accurate support location reached by the tapered portion of short sacculus and shorter labelling band.The accurate position correction of support is difficult to It is manually done by operator and needs special training.If incorrect operation, then manual positioning can cause support, cover Layer and/or sacculus are impaired.When manufacturing support to have allotment diameter or excessively allotment diameter (select big initial diameter with There is provided, when stent-expansion is to its allotment diameter, the mechanical performance improved), the work of this location can be more difficult.Support and folding Relatively large annular gap between sacculus creates significant location difficulty.
In view of these objects and foregoing problems and/or the sight of needs from this area running in the present invention/proposing Point considers, in an aspect, the invention provides: crimping head;First stop and second station, first stop and second station are arranged to Adjacent and be configured to receive the first support and the first foley's tube assembly and the second support and second with crimping head Foley's tube assembly, first stop and second station each include adjustment portion and location division;And processor, this processor is used for using First support pressure is synchronously received the first foley's tube and the second support pressure is received the second foley's tube by crimping head.When When processor receives the user instruction such as starting crimping sequence, the processor of such as local computer makes: (a) first stop makes With first stop adjustment portion, the first support and the first foley's tube are harmonized, and second station uses second station adjustment portion by second Frame and the second foley's tube are harmonized, and (b) first stop uses first stop location division the first support and the first foley's tube to be inserted into In crimping head, and second station uses second station location division that the second support and the second foley's tube are inserted into crimping head In, and (c) crimping head execution crimping sequence, the first support pressure to be received the first foley's tube, and by the second support It is crimped onto the second foley's tube.
According to a further aspect in the invention, it is provided that the machine executable code being present on machinable medium with Execution task (a) and (b) and (c).Machine readable code can include for using control system (with or without feeding back to Road) operation adjustment portion code.
Adjustment portion may include that video camera, and this video camera is for obtaining the image of the support on sacculus;Machine readable refers to Order, processor is able to access that this machine readable instructions is to be analyzed to image determine whether support is not harmonized on sacculus; Actuator, if from analyzed image, this actuator is for detecting that support is not harmonized relative to sacculus, then by sacculus and In frame one is relative to another displacement in support and sacculus, and controller, and this controller is for relative according to support Skew in sacculus controls the motion of actuator, with use actuator by support and sacculus relative to support and Another displacement in sacculus.
According to a further aspect in the invention, it is provided that a kind of method of sacculus for support pressure being received foley's tube, This sacculus has the balloon-markers of the suitable adjustment identifying support and sacculus, and the method includes: prepare for carrying out crimping Foley's tube, this preliminary step includes placing the conduit on movable carriage;Checking bracket is harmonized with sacculus, this testing sequence Including gathering support and at least one image of sacculus, then analyze image with checking bracket between balloon-markers;In inspection After testing step, support and sacculus are inserted in press-connection machine;And support pressure is received sacculus.
According to a further aspect in the invention, it is provided that a kind of compression bonding method for polymer support, the method includes Final pressure connects, and is followed by retention.During retention, sacculus and support keep at high temperature, and at stent-catheter assembly quilt Press-connection machine claw performs the leak-testing for sacculus while clamping.
According to a further aspect in the invention, it is provided that a kind of equipment for polymer support being crimped onto foley's tube, This equipment includes: have the crimping head of claw;Adjustment portion;Location division;With crimp head, adjustment portion and location division communication place Reason device;And can perform, by processor, the machine executable code that crimping processes.
Machine executable code includes: first code, and this first code is for by the ball of polymer support Yu foley's tube Capsule is harmonized and in polymer support and sacculus are positioned at crimping head;And second code, this second code is used for Polymer support is crimped onto sacculus, and this crimping step includes being set under final crimping diameter the claw of crimping head, continues With the time of staying, to allow produce pressure relaxation in polymer support and perform sacculus test, sacculus test include by Sacculus expand into certain pressure, then measures pressure within a period of time with the leakage in detection sacculus.
The scope of the method and apparatus of the present invention also covers in U.S. Publication No.2010/0004735 and U.S. Publication The technique of the crimped stent fully described in No.2008/0275537.The thickness of the pipe defining support can have between Thickness between 0.10mm and 0.18mm, is more narrowly 0.152mm or the thickness of about 0.152mm.Support can be made up of PLLA. And support can be crimped onto PEBAX sacculus.
Cross-Reference to Related Applications
All of disclosure and the patent application mentioned in this manual are had with each single disclosure or patent application Body ground and show individually in the way of being incorporated to by reference and include appointing with each described single disclosure or patent application The mode what accompanying drawing is fairly set out in this article is to same extent incorporated herein by reference.
Accompanying drawing explanation
Figure 1A is the perspective view of the crimping system according to prior art.
Figure 1B is the perspective view of the bracket of the system of Figure 1A.
Fig. 2 is the axonometric chart of support installation system, and this support installation system is configured to be in the left side of crimping head at station With right positioner with adjustment two to stent-catheter assembly, then, use crimping head and use single crimp cycle by support It is crimped onto the corresponding conduit of support.In an aspect of this disclosure, once stent-catheter assembly is in the left side of crimping head Be placed on bracket with right side, then this process is automatic, pertains only to the participation of little operator if any.
The perspective view of installation equipment that Fig. 3 is the system of Fig. 2, that include crimping head and distribution roller.
Fig. 4 A-4B is location and the close-up view of alignment system at the station, right side of the system for Fig. 2.Shown is with fixed Position and the bracket that is associated of alignment system and the element of imaging system.
Fig. 4 C is the perspective view of the bracket part of the location of Fig. 2 and alignment system.
Fig. 5 A-5C is the sequence showing the diagram reorientated by support/be again aligned on sacculus.Shown should Sequence uses the computer-controlled actuation part of location and alignment system.
Fig. 6 is another example of the mechanism of computer-controlled location and alignment system.
Fig. 7 A and Fig. 7 B describes the aspect of another example of the mechanism of computer-controlled location and alignment system.At this In example, after polymer support being clamped less diameter in advance, reorientate this polymer support.
Fig. 8 is flowchart process, which depict and uses system location and the adjustment bracket-conduit tube component of Fig. 2, then will prop up Frame is crimped onto the step that conduit is associated.
Fig. 9 is flowchart process, it illustrates and polymer support is crimped onto the step that catheter-balloon is associated.
Figure 10 is flowchart process, which depict for checking bracket adjustment on sacculus and is repositioned onto by support With the correcting bracket unregulated process on sacculus on sacculus.
Figure 11 is flow chart, it illustrates and makes PLLA support and then PLLA support pressure is received catheter-balloon and be associated Manufacturing step in some steps.
Detailed description of the invention
Run through the disclosure, the implant being made up in whole or in part that relates in no matter describing or by example of metal material The implant made such as the polymeric material of PLLA, balloon expandable implant all will be referred to as " support ".In some cases, meeting Using term " shelf ", it is in particular to for Biodegradable polymeric implant.
Fig. 2 shows the support installation system 10 according to an aspect of this disclosure.Support installation system 10 is configured to use In being positioned at by support on transmission sacculus, the most in an automated way support pressure is received sacculus.System 10 is preferably configured to Two supports can be synchronously loaded on separate foley's tube, and then, each passing through in two supports is counted Location and alignment system that calculation machine controls are placed in crimping head.Then, two supports all use same crimping head quilt It is crimped onto its corresponding sacculus.So, two supports can be synchronously crimped onto conduit in single crimping sequence process. Nursing procedure person only needs to perform the assembling of relatively simple support and conduit, and then stent-catheter assembly is installed to torr On frame.Pressing starting sequence button, now, the remainder of process need not start, so that operator is from existing The substantial amounts of manual labour typically required in system frees.
With continued reference to Fig. 2, system 10 includes the left location on left side and the right side laying respectively at crimping apparatus 12 and station of harmonizing 14 and right location and adjustment station 16, this crimping apparatus 12 includes: crimp head 20, such as iris type press-connection machine;And roller, should Roller is at the thin slice by distributing adhesion polymeric material between the support being crimped with the claw crimping head 20.Coiling Conduit 8,9 is illustrated as being arranged on location and corresponding computer-controlled left movement bracket part 42a at adjustment station 14,16 and right fortune In dynamic bracket part 42b.Bracket part 42a, 42b can perform the various merits being associated with automatic support location and alignment procedure Can, be such as positioned in crimp head 20 by catheter distal end portion (position that sacculus is positioned at) before starting to crimp sequence is suitable In position, and the support on the sacculus of adjustment conduit.After support is suitably harmonized relative to balloon-markers, will be with The conduit of support is advanced to crimp in head 20 start crimping sequence.Then, support can be before withdrawing from from press-connection machine Diametrically be reduced to final crimped status, or support partly reducing, be removed with inspection on sacculus just True placement, is then reinserted in press-connection machine completing crimping process.
The perspective view of installation equipment 12 is shown with reference to Fig. 3, Fig. 3.As it has been described above, this part of installation system 10 includes pressure Pick 20 and distribution roller.Crimping head 20 can be iris type press-connection machine, retouches in U.S. Publication No.2003/0070469 State the example of iris type press-connection machine.Crimping head 20 includes passing through left location and alignment system 14 respectively for support and conduit And right location and alignment system 16 and enter into the left hole mouth in crimping head 20 and the right hole mouth (perspective view at Fig. 2 and Fig. 3 In it can be seen that aperture or opening 20a).Preferably, crimping head 20 is configured with flexibility (compliance) off-set construction element, It allows crimping head 20 suitably to crimp one or two support.When only a support is crimped, flexible off-set construction Element can realize by adjusting the stroke of the press-connection machine claw on an end.Prop up with one not adjusting crimping two simultaneously In the case of claw load between frame, press-connection machine claw will produce the uneven power of distribution of lengths through support.
As described in Fig. 2 and Fig. 3, it is configured to synchronously crimp a favourable aspect of the crimping head of two supports For being applied to crimp the uniformity of the load on the bearing of head and support.Support can be designed as 8mm-80mm, and one Can be longer in a little application.Due to the limitation that conduit is fixing, for all of stent size, the proximal edge of support all exists Crimping head inserts identical distance.When the support of short length be arranged on right side and left side in only side time, press-connection machine Head can stand the diameter difference between high torsional load and right side and the left side in bearing.By support is positioned at pressure Pick the both sides of head, and load becomes more uniformly to be distributed or more balance, thus provide during crimping processes bigger uniformly Resistance.
Three rollers 23,24,25 are for positioning the adhesion material of cleaning before crimping between crimp jaws and support Tablet.Such as, top roller 25 remains fixed to the sheet material of liner plate.Sheet material (is not shown by the rotating mechanism in crimping head 20 Go out) pull out from liner plate.After crimping, used sheet material is collected by middle roller 24, and liner plate is collected by bottom roller 23.Make For the substitute of the roller of distribution adhesion sheet, each support all can be coated with protectiveness book, flexible before crimping Sheath.
For being covered with the support being maintained at polymer supported internal therapeutic agent, the sheet of the adhesion material of distribution (or Protectiveness sheath) for avoiding clad material accumulation on press-connection machine claw.After each crimping sequence, sheet material is by new sheet Material substitutes.By advancing the sheet material of cleaning after crimping every time, it is possible to avoid the covering material from the support being crimped before The accumulation of material.Film is also advantageous when crimping polymer support.When the metal claw of the press-connection machine strut to polymer support When applying pressure, strut can be produced infringement due to the different of the hardness between metal from polymer.Polymeric film provides More flexible surface between claw and scaffold pole, produces pit with scaffold pole during avoiding crimping.
Left location has the characteristic identical with right station 16 with station 14 of harmonizing.Therefore, explained below is applied to stand 14 or 16 In any one.Right station of harmonizing 16 includes display, this display can be used for revising or monitor simply for support and The location of the pre-programmed of conduit and alignment sequence and the interactive display 16a of follow-up crimping sequence.About specific support The information processed can obtain from input rack ID.The support ID by bar code scanning or by armature holder on After RFID transmitter have received support ID, stand and 16 can upload from remote storage area and include for specific support pressure is received The process information of the parameter/preparation of conduit, such as, balloon pressure, the time of staying, diameter reduction, temperature etc..Such as support chi The additional information of very little and balloon dimension can be uploaded according to support ID, this additional information for auxiliary stand supravasal from Dynamic adjustment, as described below.
The control knob 16a on the front panel at station 16 can be provided to start or to stop the interstage of crimping process, example As, for starting/stop support at the control knob of supravasal adjustment, for vessel clamp being tightened to bracket 42a or by conduit From the control knob of bracket 42a release, for stopping the control knob of crimping step, for support and conduit being advanced to crimping The control knob etc. removed from crimping head 20 in head 20 or by support and conduit.
As it has been described above, polymer sheet is arranged between support and press-connection machine claw.It has been found that substantial amounts of electrostatic charge Appear on these sheet materials.Additionally, when polymer support slides past balloon surface or in the preprocessing process of support, Electrostatic charge can be accumulated.For there is the polymer support more much larger than the diameter of sacculus, no matter when being shelved on sacculus Or when stent-catheter assembly is initially incorporated into crimping head and is positioned near charged polymer sheet, these are quiet Electric charge all can cause support to deviate adjustment position.For the crimping process of polymer support, it is desirable that by support-lead Pipe assembly removes or minimizes this electrostatic charge before being inserted in crimping head.For example, it is possible to it is before crimping, antistatic is empty Gas is incorporated in crimping head and makes anti-static air through stent-catheter assembly.
Stand and 16 include that bracket 42a(is hereinafter referred to as bracket 42 or bracket 42a), support and conduit are delivered by bracket 42a Neutralize to crimping head 20 and transport from crimping head 20, and assist support 100 is aligned on sacculus 112 again.Bracket 42 by being connected to translation about the computer-controlled linear driving mechanism of bracket 42.It is right with reference to Fig. 4 A-4B, Fig. 4 A-4B Location and two close-up perspective view at station 16 of harmonizing, especially, the bracket 42 support 100 being aligned on sacculus 112 for auxiliary And the close-up perspective view of the element (video camera 62 and datum plane 64) of the imaging system 60 being used together with bracket 42.Bracket 42 Including coiled portion 9a(for keeping conduit 9 by card folder 41a) pallet (tray) 41.It is convex that pallet 41 includes that near-end guides Edge 44, the axle of conduit 9 is guided into and is arranged to the front chuck 48 adjacent with conduit 46 and rear chuck 50, groove by this near-end guiding flange 44 Road 46 is directed at the entrance 22 crimping head 20 for the distal end 9b keeping conduit 9.Proximal end 9c of conduit 9 is arranged on With attachment Rule extension in position easily on pallet 41, this Rule extension provide for by pressure source (not shown) and The piezometer being associated is connected to the connection of the distal end 9c of conduit.Pressure source and piezometer are positioned to and balloon inflation lumen It is in fluid communication to carry out expanding and measuring balloon pressure when stent-catheter assembly is positioned at crimping head 20.Clip is set Part 41b is connected to the flexible pipe of Rule extension with attachment.
The conduit 46 of bracket 42 includes that outer channel member 46b and interior channel member 46a, outer channel member 46b and interior channel member 46a set It is set to form the parallel wall for being directed at by the axle 9d of conduit 9 with the entrance 22 of crimping head 20.Far-end chuck is to 48 and near End chuck includes a pair relative post to 50, and the pair of relative post is received the flexible boot abutting catheter shaft.Far-end chuck 48 are secured in place and spaced apart to provide the closely sealed space of the distal end 9b for conduit.Near-end chuck can to 50 Moved toward each other and away from each other by pneumatic actuator, with respectively the catheter shaft 9d of far-end is fastened to conduit 46 and The catheter shaft 9d of far-end is discharged from conduit 46.User's toggle switch (not shown) makes chuck 50 discharge and engage catheter shaft 9d.Therefore, chuck 50 carries out operating to be maintained in conduit 46 the distal shaft 9d of conduit 9 as fixture.Conduit 9 is at bracket 42 In be located so that sacculus 112 is positioned at the front of far-end chuck 48.In Fig. 4 A-4B, support 100 is positioned on sacculus 112.As Auxiliary during adjustment, metallic rod (not shown) is pushed in improve the anti-of distal end of catheter end by the guidewire lumen of conduit Curved rigidity.Conduit 46 includes V-shaped groove that is that formed or that have the magnetic material close to groove by magnetic material, so that conduit is in groove Harmonize, and by the magnetic force being applied on the bar being arranged in guidewire lumen, conduit is maintained at this position.
Support 100 can be manually placed to sacculus 112 by operator after sacculus 112 navigates to far-end chuck 48 On.After sacculus 112 and support 100 are appropriately positioned to the far-end chuck 48 of bracket 42, pressure toggle switch is so that near-end Conduit 9 is clamped in place by chuck by 50 polymerizations.In another embodiment, support can be placed on pallet and pass through Computer-controlled actuator propulsion bulb (being maintained on bracket 42) passes bracket holes.This bracket tray can have round The receiving surface of the bending of a part for cylindrical surface is to receive support, and this allows operator to make support drop in receiving simply On surface, receive surface naturally to make support become to stop at the central authorities receiving surface, such as, make bracket holes axis and cylinder Axis is in same plane.Flange can be formed along the remote edge on this receiving surface so that if support is to distal excursion Then support is against flange.Distal end of catheter end is advanced in bracket holes, begins to appear in support until distal balloon catheter labelling remote The far-end of end end.Contact, then in distal end of catheter end through propping up if existed between conduit with support in this step poly-period While frame aperture, distal end flange will act as stop part to keep support in place.In another example, in Fig. 6 describe and under The pallet being described more fully with in literary composition can receive support.Then, propulsion bulb distal end passes bracket holes.In above-mentioned enforcement In any one of mode, such as Fig. 6 pallet or have bending receive surface body in, support alignment procedure (as Hereinafter it is more fully described) can be performed in parallel by support is placed on the distal end of conduit.
Fig. 4 C shows the perspective view of bracket 42.As it has been described above, bracket 42 includes having the pallet 41 of rail portion 44, guide rail 46, card folder 41b and chuck 48,50.Bracket in Fig. 4 A-4B is shown as being received in groove, along with stent-catheter assembly court Moving/move away from opening 22 to opening 22, this bracket translates along groove.In bracket 42 includes being received in groove and pass through bolt 44 extensions 43 being connected to linear actuators.The chuck 50 pneumatically activated is connected to actuator by connector 50a.
Laser (or video camera) can be used to identify that the rear sealing 112a of sacculus 112 is relative to far-end with auxiliary operation person The chuck tram to 48, to guarantee that sacculus 112 and support 100 will be advanced to press-connection machine before activating crimping head 20 Appointment region in 20.If the distal end 9b of conduit is the most forward relative to chuck 48 or too close to chuck 48 For convenience, at random by chuck 48 selected as bracket 42 from the position shown in Fig. 4 A to crimping head 20 in crimping position Then, support and conduit can be incorrectly positioned in crimping head 20 the length of travel datum mark forward put, and cause To support and/or the possible infringement of crimping head.Operator adjusts distal end of catheter end 9b relative to this laser of laser The position of the red line of catheter shaft is crossed in alignment catheter shaft and generation, until the proximal seal 112a of sacculus 112 is by laser Illuminate.The front of this laser alignment chuck 48 about 10mm.
As previously described, bracket 42 and imaging system 60 auxiliary stand are in supravasal adjustment.As shown in Figure 4 A, lead (datum plane is support and conduit provides black between datum plane 64 and video camera 62 for pipe sacculus 112 and support 100 Back of the body curtain or background with distinct contrast so that the image gathered by video camera 62 can clearly recognize support and sacculus 112 Distal seal portion and proximal seal portion and/or balloon-markers).Background can be random color or can wrap if necessary Include other light source illuminating product from behind to carry out accurate dimension transition.
Datum mark can be arranged on back of the body scene plot face or on specific surface, such as, when sacculus is appropriately positioned in by operator Time on guide rail, sacculus is at the remote location of supravasal approximation and proximal location, or represents the reference index of measurement of length value, The hashed value of millimeter increment is such as shown.
As shown in Figure 4 A, after conduit 9 is positioned in bracket 42, support 100 is harmonized on sacculus 112, is followed by Crimping sequence can be started by automated procedure.Thus, then conduit 9 is suitably positioned in bracket 42, support 100 and conduit The remainder that the crimping of sacculus 112 processes can start in the case of other participation not having operator.
By the algorithm using imaging system 60 and computer to perform, support not harmonizing on sacculus can be carried out Detection, the algorithm that computer performs includes that program, the position detection programmed acquisition support 100 number on sacculus 112 are detected in position Word image and be analyzed image determining whether support is harmonized.It is to say, to gather image be analyzed with Determine the position (seeing Fig. 5 A) relative to sacculus 112, the edge 104,105 of support.In order to assist in identifying the edge of support, come Accessed from sacculus sealing, support and the balloon-markers etc. of the view data about support.Support and the length of sacculus, from limit Edge to the distance etc. of labelling and other identify that feature can be accessed remotely by support ID, then contrast with image To identify that (passing through pattern recognition program) is used for determining that support is relative to the most unregulated supporting structure of balloon-markers 114.
After support unregulated judgement is had been made, use detent mechanism so that support 100 is the most fixed Position is on sacculus 112.The computerized algorithm that can be used for again adjustment bracket includes the controller with or without feedback circuit. In both cases, controller manages to make the offset distance of support mobile computing, props up suitably to harmonize between balloon-markers Frame.
For example, referring to not having the controller of feedback, located in the picture bracket edge 104,106, sacculus sealing After 112b, 112a and/or labelling band 114a, 114b, it is possible to find support 100 relative to the position of balloon-markers and can Calculate offset distance " d1 " (Fig. 5 A).Then, this skew being input in controller, this controller controls bracket 42 and/or props up The motion of frame 100 is so that one is moved relative to another.At sacculus 112 relative to support 100 or support 100 relative to sacculus After distance d1 that 112 displacements are general, use the second image to reappraise the support position relative to sacculus 112.Identical Sequence can perform repeatedly until support 100 is appropriately positioned on sacculus 112, such as between labelling band 114a, 114b. Once calculate side-play amount d1, then support is i.e. determined relative to the motion of sacculus.If the second image demonstrates that support is still Do not harmonize, then calculate new side-play amount d1 and repeat this process.
Fig. 5 A-5C, Fig. 6 and Fig. 7 A-7B depicts can integrated arrive at a station in 16, for limit bracket relative to ball Capsule 112 or make support relative to sacculus 112(or sacculus relative to support) example of mechanism that controls of the actuator that moves.
With reference to Fig. 5 A-5C, it is positioned at rising for arm or paired arm 74, described arm or paired arm 74 below support 100 (+y) is to engage strut or the loop member of support 100.Shown a pair arm 74 at the end 104 for support 100.Arm 74a, 74b is positioned between scaffold pole, is then polymerized to clamp strut or loop member 102(Fig. 5 B).Or arm 74a, 74b can determine Position is between strut, then separately until contacting loop member or the strut of support.The two of the shown type synchronously operated Can be with an arm (or post) at the two of limit bracket end 104 and 106, or each end 104,106 to arm (that is, arm 74) (+y) can be risen for use as the horizontal movement (fitting of +/-x) so that sacculus preventing support 100 relative to sacculus 112 112 can move relative to support 100.With reference to Fig. 5 B-5C, such as, while support is kept by arm 74, bracket 42 is transported forward Dynamic distance d1.After bracket 42 moves, arm 74 retracts to its original position.Obtain support 100 and the second figure of sacculus 112 Picture, as shown between labelling band 114a, 114b to determine whether present support 100 is positioned at.With reference to Fig. 6, in alternative In case, when reorientating sacculus 112, including multiple protruding 77(arranged upward such as, square extension, protuberance) or have The bolster 76 on coarse (rubber-like) surface 77 of great friction coefficient may be used for limit bracket 100 and moves.Alternatively, bolster 76 can be with horizontal ground motion (-x) so that support 100 moves relative to sacculus 112.As described above, this pallet 76 can also For support 100 is placed on conduit 9.
With reference to another embodiment that Fig. 7 A-7B, Fig. 7 A-7B are support adjustment mechanism.As retouched more fully below Stating, shown is reduced to about 1/2 size of its initial diameter for support 100 its diameter after pre-crimping step.Fig. 7 A, Fork shown in 7B 150 for engaging proximal end 105b of support 100, with through sacculus 112 promotes forward support 100 until End 104,105 is between balloon-markers 114.Pitch 150 pre-determined bit become adjacent with bracket 42, then pass through linear actuators to Front motion.Fork 150 includes from the upwardly extending relative arm 152,154 of root.Show for fork 150 is connected to actuator The connector 156 of arm (not shown).The inner surface 158 of fork 150 is configured to circular surface and will be sized such that at ball Small gap is there is between capsule surface and surface 158.Thus, along with the fork 150 left side motion in Fig. 7 A, surface 158 is slightly Cross the outer surface of sacculus 112, and when arriving support 100, fork 150 abutting end 105a.Fork 150 and support 100 are according to control Device logic (below) processed continues through sacculus 112 distal movement, until the offset distance represented in support 100 motion diagram 7A d2。
Being positioned too by far-end at support 100, i.e. edge 104 is in the case of the far-end of balloon-markers 114b, then may be used Similar fork 150 is arranged the left side of support with proximally facing balloon-markers promotion support.Identical fork 150 may be used for Correction far-end does not harmonizes or near-end is not harmonized.Alignment adjustment as required fork 150 can be repositioned at the remote of support 100 End or near-end.When needs are harmonized, preferably make not harmonize the always type shown in Fig. 7 A, because in this situation Downcomer is stretched rather than is compressed, and interferes along with support 100 exists support-sacculus relative to sacculus 112 athletic meeting.
As indicated previously, before pre-crimping, the diameter of polymer support can be more much larger than the diameter of sacculus 112 (Fig. 5 A).For the adjustment again under this stent diameter, owing to support 100 easily moves through sacculus 112, therefore deposit Needing to carry out to the left, near-end readjusts needs or exist to need to carry out to the right needs that far-end readjusts also Do not produce the biggest difference.But, when crimping step (Fig. 7 A) diameter of polymer support in pre-crimping step in advance When needing again to harmonize after having had been decreased to the degree that polymer support starts to engage balloon surface, can exist Expected from the interaction of support-sacculus to a certain extent.This is that the purpose from the diameter of pre-crimping draws.Diameter is selected It is selected to so that support can not be movable easily, but remains able to when needs are harmonized again move relative to balloon surface.Such as it Before be previously mentioned, this highlight that polymer support faces but in metal rack non-existent another problem.As carried before Arrive, for reasons of the mechanical performance under the diameter carrying out allocating, for polymer support, use big initial diameter. But, bigger diameter (relative to sacculus) also increases the support when performing the reduction of initial diameter and will translate relative to sacculus Probability.Accordingly, it would be desirable to removed by support after initial diameter reduces, it is reduced to need not into one with the diameter at support Before the adjustment of step, support is properly aligned and tests.
As shown in Figure 7 A, when support is not harmonized relative to balloon-markers, promote forward support.Any due to support-ball The resistance that capsule contacts and produces support motion all will produce acceptable tension force in the catheter.But, if support 100 sets Put at the far-end of distal balloon catheter labelling and need again to harmonize at near-end, then due to sacculus-support contact produce right The resistance of motion will make distal end of catheter end 9b compress, and this can make the end off-axis of conduit, makes again alignment procedure more Difficulty (because conduit transverse movement while support is relocated).
This problem can be solved by following manner: keeps distal end 9b when pitching 150 proximally facing end motion; Or use alternate mechanism (as required) with along with support 100 be moved in distal tip is maintained on axis while press from both sides Live and traversing carriage.Such as, in alternative embodiment, the upper surface of the pallet 76 in Fig. 6 is bending or includes one To relative curved surface, the pair of relative curved surface polymerization is to clamp the surface of support 100, then when end 9d quilt When being maintained on axis, this pallet is displaced to near-end.Alternatively, the initial alignment of support 100 may be located at proximal balloon mark The near-end of note, so that it is guaranteed that any displacement in precompressed termination process will not result in support 100 is positioned at the remote of distal balloon catheter labelling End.
The sequence of computer using the aforesaid operations of one or more computer-controlled actuating mechanism is controlled, This computer such as has personal computer or the PC or work station: DRAM of following device;Disk memory;Hardware bus; CPU;The such as user input apparatus of touch screen 16a, keyboard, mouse;External drive;And to LAN network connect and be used for Control the driver of actuator for driving the mechanism described in Fig. 5-6.Being present in the computer at the 16a of station can be by remote Journey ground uses LAN, WAN or other network type to access the information about support and conduit, and this information can be taken by file Business device conducts interviews.The machine executable code being associated with the algorithm aspect of alignment system can be that software realizes or hardware Realize or a combination of both.Ready-made equipment may be used for imaging system 60 above-mentioned and actuator.
The image gathered by video camera 62 determines the far-end/proximal seal portion of bracket edge 104,105 and sacculus 112, the position of 114 can realize by using algorithm for pattern recognition, and as previously mentioned, this algorithm for pattern recognition can be by The image of video camera 62 contrasts with the information of the pre-stored about the length of support and/or pattern, to distinguish in the picture Support 100 and sacculus 112.The other parts of balloon-markers Yu such as support and conduit 9 carry out difference can be by using This light of light by with make in the way of around image is contrasted balloon-markers be irradiated by light in specific band to illuminate Frame and sacculus realize.Identical technology can also be based on being irradiated stent markers then calculating bracket edge relative to this The position of a little labellings and be used for finding out bracket edge.Can be programmed algorithm for pattern recognition receiving support as input Length, the position of labelling and pattern, the diameter of pre-crimping, the length of balloon of far-end/between proximal seal portion and labelling, and defeated Going out signal to harmonize or offset distance with sacculus with instruction support, then this offset distance is received by a controller with relative to sacculus 112 reorientate support 100.
As mentioned before, the controller of feedback circuit is used to may be used for being repositioned on sacculus support.Should The feedback of controller can be as support or sacculus is movable with respect to from support relative to the image in sacculus centre position The positional information extracted.Thus, such as, support is moved the distance of growth and obtains the image of new position.To actuator Next input, such as, inputs servo control mechanism and calculates based on from the feedback information of image zooming-out, performs what next increased Displacement, obtains the 3rd image etc. until offset distance is close to zero, i.e. support is between balloon-markers.Control system is permissible Use PID to control or state-space controls logic to calculate next input to actuator.Actuator can pass through servo control mechanism Or motor is controlled providing being accurately controlled of the motion to actuator.
It is of course desirable to be used without the closed circuit or open circuit feedback control for support being positioned repetition between the marks Processing mode.But, owing to mentioning before, it is repeated several times when support being reorientated after pre-crimping It is necessary.When needing again to harmonize after pre-crimping, substantial amounts of delayed being incorporated in system can be needed by sacculus Mode to be repeated.
As previously described, the precompressed of support connects and aims to provide enough frictions so that support can not be movable easily, Rather than too much friction is provided and hinders reorientating whenever necessary.Pre-crimping reduces diameter surveying more accurately Distance between amount bracket edge and labelling band.Major part in the defect caused because of the distortion of support and support motion is in precompressed Connect in step process and occur.In this sense, it is proper that by merging disclosed alignment system after pre-crimping , there is the possibility that support is finely harmonized when support closely its final diameter and shape in aspect.
Fig. 8-10 describes for being positioned and harmonized conduit and support and in crimping head 20 by use system 10 The handling process of crimped stent.
With reference to Fig. 8, process starts from operator and reads the mark (ID) of the support being crimped onto conduit.Location, adjustment are so After to carry out the support at the process that the crimps left station 14 or right station 16 for being positioned at system 10 identical with conduit.When two stations 14,16 When being used for synchronously support pressure being received conduit 8,9, two stations can be controlled by central processing unit, or each station 14, Process can be controlled by the single processor at 16 until support and conduit are inserted in crimping head 20 at any time Moment, in this moment, central controller adapter crimping step.One aspect of crimping process crimps step in advance and is followed by removal Support and conduit are to check adjustment.For this step, control to give back the processor at station 14,16 to perform inspection and can Can adjustment again, be followed by control is given back central processing unit (or only one station 14,16 processor perform crimping sequence Row, and another processor keeps the free time).
With reference to the handling process of Fig. 8, by support ID is input to computer control, process control can be led to by operator Cross user display 16a to select, or these controls can be based on input rack ID automatically from memory search.Then, Conduit 9 is loaded on adjustment bracket 42.Coiled portion 9a of conduit 9 is placed on pallet 41.This is carried out by operator Manual operation.Proximal end 9c of support is oriented in the face of card folder 9c, and coiled portion 9a is placed on pallet 41 and wraps The axle 9d including proximal end 9b is aligned by the far-end of guide rail 44 and the location of chuck 48.Rule extension is attached and presses Power source is connected to this Rule extension.Operator presses the button so that chuck is to 50 polymerizations, from face, conduit is clamped in bracket In 42.Then, the proximal seal portion 112a of sacculus 112 relative to far-end chuck 48 position by check illuminating ray whether according to The proximal seal position being mapped to sacculus test (if or unregulated words, video camera is checked suitable position and passes through Green glow or HONGGUANG indicate this position).If be properly aligned, ensuing flow process advances to support alignment sequence (Figure 10), Without being properly aligned, fixture release and operator are reorientated the distal end 9b of conduit, until rear sacculus Sealing is harmonized with datum ray.As previously described, manually or by automatic installation process, support can be placed On conduit.
With reference to the handling process of Figure 10, by the signal received from operator, such as, start button is pressed to start crimping Sequence, then, controls transitions to support and harmonizes the stage (or by using same mechanism and control system that support is placed on sacculus Go up and carry out the stage harmonized) to determine whether support is properly aligned relative to balloon-markers.Location bracket 42 will be led The position that the distal end 9b of pipe and support 100 are advanced to be suitable for is to check adjustment, i.e. support and sacculus are positioned in video camera The central authorities of the camera aperture address of 62.In this position, the image of camera acquisition may be used for extracting support relative with sacculus The range information of position, and backing positions is adjusted, as previously described.
After acquiring one or more digital picture, the information of support and conduit is recovered and determines support with auxiliary Edge and balloon-markers and/or the exact position of sealing.Such as, the distance between distal balloon catheter sealing and balloon-markers can For determining that distal balloon catheter labelling is positioned at where relative to distal seal portion, as crossed the situation of balloon-markers at bracket edge Under, thus the ken (Fig. 5 A) of fuzzy video camera 60.By about the length of support, the pre-crimping diameter of support, support pattern, Stent markers is relative to the information of the position etc. at edge, the mark being marked in digital picture or with the information from image mutually Other pattern joined, algorithm may determine that bracket edge is positioned at where.
By bracket edge and balloon-markers being positioned, controller (with or without feedback circuit) determines support and is No it is aligned, or support or sacculus are the need of relative to each other moving so that the fore-stock in crimping is between balloon-markers Between (as required).If support is aligned between balloon-markers, then control signal be transferred to central controller with Support and sacculus is made to move to crimp in head 20.If it is determined that support is not harmonized, then support is such as by using Fig. 5-7 Described in mechanism mobile relative to sacculus (or sacculus is relative to support).After support is harmonized with balloon-markers, then Support and conduit all set crimp.
There are two possible support positioning sequences occurred during crimping process.First ray can include not pressing The support connect is relative in labelling band pre-determined bit to conduit.During the initial alignment stage preferably, mount proximal end is not made Be biased to desired position so that the final location after pre-crimping can always by relative to conduit promote rack far end by This makes conduit tensioning rather than has compressed.Second possible positioning sequence crimps final after can being included in pre-crimping Before by support pre-determined bit to conduit.Owing to can not move relative to sacculus at the after-poppet of final crimping, therefore this needs If final position.
With reference to the general process for crimping of Fig. 9, bracket is pushed forward under the control of the computer and enters press-connection machine head 20 In to guarantee to add and to be placed in press-connection machine time will not translate.The first diameter produced by press-connection machine being referred to as pre-crimping reduces Stent diameter is reduced about 1/2.As indicated on, the strut of support is not pressed in balloon material, but has opened Begin to engage this material.After pre-crimping, the removal from crimping head 20 of support and sacculus makes support 100 relative to sacculus mark The position of note can be examined before final crimping starts again.Then, control transitions to combine the process that Figure 10 describes. After process sends the signal that support and sacculus are suitably harmonized again, support and sacculus are replaced crimping head 20 In.Final crimping step starts.Figure 11 illustrates the example for these crimping steps preferred embodiment, connecing At a temperature of its glass transition temperature nearly, PLLA support is crimped, and diameter is reduced to about the 1/ of pre-crimping diameter 2.5。
Can be to use the heating of one or both forms during crimping process.Heating can be by heating crimping head Claw realizes, or can use hot-air in addition to heating press-connection machine claw.Use hot-air and from press-connection machine claw Both conduction and radiation are favourable.This combination of thermal source can make balloon material more easily flow between scaffold pole Between gap.Additionally, simultaneously use hot-air to reduce by adding from the conduction of claw and radiation together with the claw of heating Temperature required for hot support and sacculus.This be preferably make support surface will not overheated and while being crimped not Damage can be caused.Thus, by using the combination of air and the claw of heating, the temperature of claw can be reduced.
As from Figure 11 it should be understood that due to polymer support need the substantial amounts of time of staying, therefore exist multiple in Between crimp step.This is because if diameter reduces with too high speed, unacceptable crack can be developed.Need slowly, Cumulative crimping process makes internal stress oneself to eliminate.It is desirable that from the viewpoint of intensity/integrity, polymeric material Material can plastically deform (such as, through several hours) under extremely low speed.But, from the viewpoint of producing, this is actual 's.Crimping step shown in Figure 11 is found to produce acceptable yield.When in view of performing as shown in Figure 11 During substantial amounts of time required for the crimping sequence of polymer support, then it will be appreciated that the advantage of automatic system 10.
The crimping stage 4 in final crimping step i.e. Figure 11 includes the time of staying of 200 seconds.When press-connection machine claw is in this position Put when remaining fixed on scaffold pole (to carry out stress relaxation and to minimize recoil after support is removed at claw), sacculus It is expanded to the pressure of about 200 pounds/square inch to perform leak-testing.After the stop of leak-testing and 200 seconds, will Support and conduit remove from press-connection machine, by sheath on support, and support and conduit are placed in refrigeration unit.Send out Existing, in addition to decreasing the time required in process of production, it is also advantageous to when Polymer-supported during the time of staying Frame is positioned in crimping head and is crimped when machine claw limits and performs leak-testing.First, by high temperature increasing sacculus Pressure, the pressure owing to increasing makes sacculus fold with the space finding it between scaffold pole, and therefore sacculus-support contact can To strengthen.This can increase support retentivity on sacculus.Secondly, the low profile (profile) of support-sacculus is possible 's.
In normal conditions, such as when using the equipment of Figure 1A-1B, leak-testing removes also from crimping head at support And perform afterwards in being inserted into restriction sheath.When performing leak-testing, will than the restriction sheath of press-connection machine claw more radial compliance Carry out a certain degree of expansion.Preferably keep the least profile.Thus, hold in crimping head if revealing test OK, though due in sacculus pressure increase press-connection machine claw diameter will be kept, therefore maintain less profile.
While there has been shown and described that the specific embodiment of the present invention, but the most obvious , in the case of without departing from the widest aspect of the present invention, can make a change and retrofit.Therefore, described right is wanted Ask and be intended in the range of it in the way of falling within the scope of the invention, contain all these change and remodeling.

Claims (12)

1. an equipment, including:
Crimping head, described crimping head has claw and adhesion material, and described adhesion material is arranged to be placed on Between the support received in described claw and described crimping head;
First stop and second station, described first stop and described second station are arranged to adjacent with described crimping head and construct composition Do not receive the first support and the first foley's tube assembly and the second support and the second foley's tube assembly;
Described first stop and described second station each include adjustment portion and location division;And
Processor, described processor is used for using described crimping head, synchronously described first support pressure is received described first Foley's tube and described second support pressure is received described second foley's tube,
When receiving user instruction, described processor makes:
A () described first stop uses first stop adjustment portion to be harmonized with described first foley's tube by described first support, and institute Stating second station uses second station adjustment portion to be harmonized with described second foley's tube by described second support,
B () described first stop uses first stop location division that described first support and the first foley's tube are inserted into described press-connection machine In Tou, and described second station uses second station location division that described second support and the second foley's tube are inserted into described crimping In head, and
C () described crimping head performs crimping sequence, described first support pressure to be received described first foley's tube, and will Described second support pressure receives described second foley's tube.
Equipment the most according to claim 1, wherein, described crimping head includes flexible adjusting apparatus, described flexible adjustment Device is for adjusting the stroke of the claw in described crimping head so that is once only capable of and presses a support and conduit Connect, or can two stent-catheter assemblies be crimped simultaneously.
Equipment the most according to claim 1, described processor is also configured to exert a force to be arranged on institute at described claw While stating described first support in crimping head and the second support, described first foley's tube and described second sacculus are led Test is revealed in both execution of pipe.
Equipment the most according to claim 3, wherein, described first support and the second support are polymer support.
Equipment the most according to claim 4, wherein, described first support and the second support are made by gathering left lactic acid.
Equipment the most according to claim 1, wherein, described adjustment portion includes:
Video camera, described video camera is for obtaining the image of the support on sacculus;
Machine readable instructions, described processor is able to access that described machine readable instructions is to be analyzed to determine to described image Whether support is not harmonized on sacculus;
Actuator, if from the image analyzed, described actuator is for detecting that support is not harmonized relative to sacculus, then makes to prop up In frame and sacculus one is relative to another displacement in support and sacculus;And
Controller, described controller is used for controlling relative to the skew of sacculus the motion of described actuator according to support, so that One in support and sacculus is made relative to another displacement in support and sacculus with described actuator.
Equipment the most according to claim 6, wherein, described processor is also configured to when described processor receives from institute During signal that state adjustment portion, that show support and be aligned on sacculus, described location division is made automatically support and sacculus to be advanced In described crimping head.
Equipment the most according to claim 7,
Wherein, described actuator makes sacculus relative to stent migration;And
Wherein, described location division also includes:
Bracket, described bracket is used for supporting support and conduit;And
Described actuator, for when receiving command signal from described processor, shifts described torr towards described crimping head Frame, thus support and conduit are advanced in described crimping head.
Equipment the most according to claim 8, wherein, described bracket includes:
Pallet, described pallet is for receiving the conduit of coiling;
Conduit, described conduit is connected to described pallet with by the distal end of described conduit and the described opening pair crimping head Standard, and
Chuck, described chuck for being tightened to the guide rail of described pallet by described vessel clamp.
Equipment the most according to claim 8, wherein, described location division also includes optical alignment device, described optical alignment Device is for relative to the position adjustment proximal balloon sealing on described bracket, to guarantee that support and conduit will be by described actuatings Device is advanced to the suitable position in described crimping head.
11. equipment according to claim 8, wherein, described processor includes being present in described first stop and described second The personal computer at one or both in standing or work station, wherein, described personal computer or work station include for grasping Make described location division and the device driver based on software in described adjustment portion, input/output device, display, storage medium And network connects.
12. equipment according to claim 1, wherein, described processor is configured to receiving described first support and institute When stating the identification code of the second support, automatically access from memory block and limit the crimping parameter of described crimping sequence and support and conduit Attribute.
CN201180033155.XA 2010-07-07 2011-07-07 Support installation on support delivery system Expired - Fee Related CN102970944B (en)

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JP2016028690A (en) 2016-03-03
CN102970944A (en) 2013-03-13
US20120010693A1 (en) 2012-01-12
JP5995209B2 (en) 2016-09-21
US8752261B2 (en) 2014-06-17
CN106137487A (en) 2016-11-23
JP5805185B2 (en) 2015-11-04
WO2012006451A1 (en) 2012-01-12
JP2013533794A (en) 2013-08-29
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US20140230225A1 (en) 2014-08-21
EP2590601A1 (en) 2013-05-15

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